Clinical trials: Sponsors and sponsor-investigators

In the conduct of a clinical trial, a sponsor is an individual, institution, company or organization (for example, a contract research organization) that takes the responsibility to initiate, manage or finance the clinical trial,1 but does not actually conduct the investigation.

A sponsor-investigator, on the other hand, takes on the responsibility as a clinical study sponsor and also conducts or oversees the clinical trial. Thus, a sponsor-investigator must comply with the applicable regulatory requirements that pertain to both the sponsor and the investigator.2,3

Clinical trials: Study sponsor responsibilities

The specific regional requirements for a clinical study sponsor can vary. Generally, a sponsor is responsible for:3,4

Selecting the investigator(s)

Providing investigator(s) with the necessary information to conduct the clinical trial

Ensuring proper monitoring of the clinical study

Ensuring all the necessary ethic review(s) and approval(s) are obtained

Preparing and submitting clinical trial application(s) and amendment(s) to the appropriate regulatory agencies

Ensuring that any reviewing ethics board and regulatory agencies are promptly informed of any significant new information (for example, important findings that affect product safety) in a clinical study

Conducting the clinical study (that is, directly overseeing the administration of the test products to the subject). In situations where there is a team of researchers, the investigator will act as the team leader

Ensuring that the clinical trial is conducted in accordance with the signed agreement and the investigational plan

Controlling the products under investigation (for example, supervising medical-device use and disposal)

Meeting all the applicable regulatory requirements such as obtaining and maintaining necessary approvals from the relevant ethics review boards and regulatory agencies

Sponsor-investigators: Getting started with a clinical trial application

While the completion of a clinical trial application involves many tasks and may seem daunting, there are many resources to help. The following approach can assist you:

Research the regulatory requirements pertaining to the applicable submissions. Make good use of regulatory agency websites and professional organizations as well as related publications, seminars and training.

Prepare and submit the application based on the format and content relevant to the specific submission. Make sure that any comments or feedback received at the pre-submission meeting are incorporated in the submission dossier.

After a submission is approved, ensure that all the post-approval requirements are fulfilled, such as any required safety reporting, annual reporting and amendment submissions relating to significant changes to the products or study plan.

Make certain that you fulfill your responsibilities as a sponsor as well as an investigator according to applicable regulatory requirements.

Disclaimer

The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.

Published: October 17, 2012

References

International Conference on Harmonisation. (1996, June). E6(R1): Good clinical practice. Retrieved September 25, 2012, from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf.

European Community. (2001, April 4). Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities. Retrieved July 13, 2012, from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF.